Validation Documentation Suites an introduction.

The use of a professionally Validation packages, or suites of documents is a simple way  of ensuring that your visiting regulator's first impressions will be favorable.   Inspectors expect to see a complete suite of validation documents in place for each validation task.  The use and scope of the individual documents has been documented, discussed and explained in detail.  It is therefore obviously best policy to have in place exactly what the regulator is looking for.  This is the reason why eight years ago; when we ran a questionnaire on our site, two requirements stood head and shoulders above all else;

1.      Complete Documentation Packages.

2.      A combined IQ/OQ/PQ Protocol for laboratory instruments.

The use of a document packages ensures a multitude of regulatory requirements are catered for and possibly a similar multitude of pitfalls, blunders and omissions are anticipated and negated.  

After due diligence is used to review the current Good Manufacturing Practice (cGMP) legislation (21 CFR Part 11/210/211/820) along with the FDA guidance documents (not mandatory but probably advisable) it becomes rather obvious why there is cascade of documentation and why each document in this cascade is obligatory. 

At this stage it becomes rather obvious that the suite of documents we produce is exactly what the regulators expect to find already in place.  These documents sequentially cascade from the URS through VRA, DQ, IQ, OQ, P1Q and finish with the P2Q.  This progression is of the utmost importance since the documents are inter-referenced and must be executed sequentially.  This is one of the main reasons why it is important that the documents are designed and written as a package where the correct sequential and chronological sequences can be authored in; across all the relevant documents.

Validation Documentation Suites.

Numerous validation inquiries led us into collating various validation documents to form validation suites containing all the required protocols; along with the supporting documents, such as the VP and the VRA. This simplifies the user selection task. The packages have been arranged for three levels of validation for process, production, facility and utility equipment and separate bespoke packages for Software, HVAC, Networks and other stand-alone systems.

Validation Packages.

The complete chain of regulatory required documentation required to enable satisfactory for for the validation of a computer / DCS / PLC / ERP, system. This Validation Package contains one of each of these documents VP - URS - DQ - VRA - IQ - OQ - PQ.

HVAC New System Qualification Package

This package is targeted at the new build where the original design concepts are translated into a URS. From which the full flow of qualification documentation can be generated, and correctly cross referenced. Therefore we start with the VP and progress to the URS - VRA - DQ - IQ - OQ and PQ.

HVAC Validation Package.

The complete suite of DQ, IQ, OQ and PQ are bundled here for the end users ease of ordering, also allowing a discount for the multi-document purchase.

Level One.

You want to validate a relatively minor, new or replacement piece of equipment that is going to be used within a facility that is fully validated and subject to change control.
In this case you require :- IQ, OQ, PQ.

Level Two.

You want to validate a process line that has been subjected to major modification, but is validated and is continuing to use the same processes to produce the same product.
In this case you require: VP, URS, IQ, OQ, PQ.

Level Three.

You have a new facility and you want to validate it. In this case you require:-
VMP, The global master plan for the whole facility.
cVMP, The master plan for all computer systems.  VP, which will define validation boundaries, methodologies and responsibilities.
URS, DQ, VRA, IQ, OQ, PQ. For each piece of equipment.


Document Relationships.

This graphic depicts the use of validation packages

VMP & VP Correct Use.

This graphic portrays the relationship between validation protocols as used in our Validation Packages.rrepresents


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SOP for Spreadsheet Creation.

Why does something as simple as a spreadsheet figure in so many regulatory citations? Good question; and at times a difficult one to answer. When you ask a group of compliance personnel the same question you will be informed that Excel cannot be validated because it does not seal the original copy (of the spreadsheet), allows the original to be modified and has an audit trail that can be disabled. All true, but none of these problems interfere with your ability to validate that the spreadsheet is fit for purpose. They only preclude you from using the spread sheet as a compliant repository for any data that has to be store in compliance with 21 CFR Part 11.
If the spreadsheet is signed off and dated by the user, their supervisor and QA, it becomes regulatory acceptable data stored in hardcopy, and Part 11 does not apply.
After numerous requests for this, we have launched our brand new SOP for Spreadsheet Creation to cover these and other known target points that the regulators consistently hone into as soon as they find that spreadsheets are being used. Use this Spreadsheet Creation SOP to ensure that you create spreadsheets that are validatable. Then use our spreadsheet validation pack to validate them.

SOP for Spreadsheet Creation. -- $125.00


SOP Equipment Validation.

The SOP for Computer Equipment Validation continues to be an extremely popular document. This document leads you through the validation process, from the URS to the final P2Q.

Purchase your copy now at Special Price of $22.00.


Validation Risk Assessment (Issue11.) -- $125.00

The Risk and Part 11 Validation Risk Assessment (VRA) protocol is becoming the most important document in the validation train. The VRA reassures the regulators that you have looked at specific equipment functionality and considered the appropriate level of validation that is required. You have also considered various aspects of its use and the implications of any malfunctions. From the results of this exercise the scope of all validation activity can and must be justified. This is a robust and simple to execute document, one that will lead you through the process and deliver a result that can be used as the foundation for your validation activities.
This VRA now includes the assessment table for categorizing and documenting the new 21 CFR Part 11 guidance ruling on what predicate data must be stored in a Part compliant system, along with the new broadsheet to establish your new database of part 11 records. (now mandatory).


Equipment combined IQ/OQ/PQ Protocol.

This combination protocol has been produced in response to several hundred reader suggestions we received in our ‘Suggestions Section’. It has been carefully designed to make it the preferred choice for Process and Laboratory stand alone equipment. It is interactive, easy to use and suitable for all mixes of equipment with and without software.
The IQ section establishes documented verification that key aspects of the equipment adhere to approved design intentions and that the recommendations of the manufacturer have been suitably considered. The OQ section establishes that there is documented verification that the installed system functions as specified and that there is sufficient documentary evidence to demonstrate this. The PQ section gives documented verification that the equipment performance in its normal operating environment is consistently exactly as specified in the URS.